NCT02096315终止2 期
A Phase II, Open-label, Multicenter Study to Assess the Tolerance, Safety, Efficacy and Pharmacokinetics/Pharmacodynamics (PK/PD) of POL7080 in the Treatment of Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis Due to Pseudomonas Aeruginosa Infection Requiring Intravenous Treatment
Polyphor Ltd.4 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Sputum bacterial clearance
研究概览
简要总结
To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.
详细描述
- Patients will be recruited after written informed consent.
- Adverse events will be coded using Medical Dictionary for regulatory activities (MedDRA).
- Descriptive statistics will be used for all the safety and efficacy variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged ≥18 to <80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection
- •Sputum sample collected for culture before starting treatment
排除标准
- •Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception
- •Subjects suffering from cystic fibrosis, active pulmonary mycobacterial infection, end stage chronic obstructive pulmonary disease on long term oxygen therapy, severe uncontrolled asthma, active sarcoidosis and active allergic broncho-pulmonary aspergillosis
- •Current exacerbation of bronchiectasis is associated with lung abscess or empyema
- •Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa
- •Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
- •Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent
研究组 & 干预措施
POL7080
Experimental
POL7080 administered daily
干预措施: POL7080 (Drug)
结局指标
主要结局
Sputum bacterial clearance
时间窗: Day 4, Day 5, Day 10, Day 15 and Day 20
Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa
次要结局
- Adverse events(Daily assessment up to 20 days from informed consent.)
- Laboratory abnormalities.(Day 4, Day 10, Day 15 and Day 20)
- Volume of sputum in 24 hours(Day 4, Day 10, Day 15 and Day 20)
研究者
研究点 (4)
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